Bipolar forceps having a cutting element

ABSTRACT

In various surgical techniques, a bipolar forceps can be used to seal a vessel in two locations such that the vessel can be incised at a location positioned intermediate the two seal locations. The bipolar forceps can include a cutting element which can be configured to incise the vessel. In various embodiments, the cutting element can include a sharp edge which can be moved relative to the vessel. In at least one embodiment, the cutting element can be electrically connected to a source of energy. The bipolar forceps can include first and second electrodes positioned within first and second jaw members, respectively, wherein at least one of the jaw members can include a substantially tapered profile and can be configured to pull the vessel away from the surrounding soft tissue. Such jaw members can include ridges, teeth, and/or a textured outer surface configured to grip the soft tissue and/or vessel.

RELATED APPLICATION

The present application is related to U.S. patent application Ser. No.______, entitled BIPOLAR FORCEPS, Atty. Docket No. END6184USNP/070285,which is a commonly-owned U.S. patent application filed concurrentlyherewith, the entire disclosure of which is hereby incorporated byreference herein.

BACKGROUND

1. Field of the Invention

The present invention generally relates to electrical ablation surgicalinstruments and, more particularly, to bipolar forceps for performingvarious surgical techniques.

2. Description of the Related Art

Previous bipolar forceps have included a grasping device which isconfigured to grasp and manipulate soft tissue, for example. In variouscircumstances, the grasping device has included a first electrode and asecond electrode where, when one of the electrodes is brought into closeopposition to the other electrode, an electrical current can passtherebetween. More particularly, when soft tissue is captured betweenthe electrodes, current can be supplied to the first electrode and flowto the second electrode through the soft tissue. In such circumstances,the current can cauterize, vaporize, and/or otherwise treat, the softtissue. Previous bipolar forceps, referring to U.S. Pat. No. 5,944,718,the entire disclosure of which is hereby incorporated be referenceherein, have included a first electrode which can be pivoted relative toa stationary second electrode. These forceps have further included afirst wire attached to the first electrode where the first wire isconfigured to supply current to the first electrode from an electricalsource. In addition, these forceps have included a second wire which isattached to the second electrode where the second wire is configured tocomplete the electrical circuit and return the current back to theelectrical source. In order for the first wire to remain in electricalcommunication with the first electrode when the first, or movable, jawmember is pivoted, the first wire must often bend and/or stretch inorder to accommodate this movement. In some circumstances, such bendingor stretching may cause the wire to break and/or the insulation coveringthe wire to become chaffed, thereby rendering the surgical instrumentinoperative or unreliable. What is needed is an improvement over theforegoing.

SUMMARY

In at least one form of the invention, a bipolar forceps can include afirst electrode, a second electrode, and a conductor, or wire, operablyconnected to an electrical source, for example, wherein the conductorcan be selectively placed in electrical communication with the firstelectrode when the first electrode is moved between open and closedpositions. In various embodiments, the wire can include a contact endwhich is not in contact with the first electrode when the firstelectrode is in its open position. In such an open position, the firstelectrode may not be in electrical communication with the electricalsource and, as a result, current may not flow through the firstelectrode. In at least one such embodiment, the first electrode can bemoved into its closed position such that the first electrode is incontact with the contact end of the wire. In such a closed position, thefirst electrode may be in electrical communication with the electricalsource allowing current to flow through the first electrode. As a resultof the above, the first electrode can move relative to the wire suchthat the wire does not have to move with the first electrode when thefirst electrode is moved between its open and closed positions and, as aresult, the likelihood that the wire may become damaged or broken can bereduced.

In at least one form of the invention, a bipolar forceps can include twoor more electrodes wherein the electrodes can be positioned against, oradjacent to, a vessel, such as a blood vessel, for example, and energycan be supplied to the electrodes. In various circumstances, the energycan be sufficient to at least substantially seal the vessel such thatblood does not substantially flow therethrough. In at least one surgicaltechnique, the bipolar forceps can be used to seal the vessel in twolocations such that the vessel can be incised, or transected, at alocation positioned intermediate the two seal locations. In at least oneembodiment, the bipolar forceps can include a cutting element which canbe configured to incise the vessel. In various embodiments, the cuttingelement can include a sharp edge which can be moved relative to thevessel. In at least one embodiment, the cutting element can beelectrically connected to a source of energy wherein the energizedcutting element can be configured to incise the tissue.

In at least one form of the invention, a bipolar forceps can includefirst and second electrodes positioned within first and second jawmembers, respectively, wherein at least one of the jaw members caninclude a substantially tapered profile. In various surgical techniques,the jaw members can be positioned in a substantially closed positionsuch that the distal end of the jaw members can be positionedintermediate a vessel, for example, and tissue at least partiallysurrounding the vessel. Thereafter, in at least one surgical technique,the jaw members can be opened in order to pull the vessel away from thesoft tissue. In various techniques, the jaw members can be opened andclosed repeatedly to enlarge a hole between the vessel and the tissueand/or otherwise separate the vessel from the tissue. In at least oneembodiment, at least one of the jaw members can include ridges, teeth,and/or a textured outer surface configured to grip the soft tissueand/or vessel.

BRIEF DESCRIPTION OF THE DRAWINGS

The above-mentioned and other features and advantages of the variousembodiments of this invention, and the manner of attaining them, willbecome more apparent and the invention itself will be better understoodby reference to the following description of embodiments of theinvention taken in conjunction with the accompanying drawings, wherein:

FIG. 1 is a perspective view of a hand piece and a shaft assembly of asurgical instrument in accordance with an embodiment of the presentinvention;

FIG. 2 is a schematic of an electrical source and an actuator for usewith the surgical instrument of FIG. 1 in accordance with an embodimentof the present invention;

FIG. 3 is an elevational view of an end effector and a shaft assembly ofa surgical instrument in accordance with an embodiment of the presentinvention;

FIG. 4 is a perspective view of the end effector of FIG. 3;

FIG. 5 is an additional perspective view of the end effector of FIG. 3;

FIG. 6 is a left elevational view of the end effector of FIG. 3;

FIG. 7 is a right elevational view of the end effector of FIG. 3;

FIG. 8 is an end view of the end effector of FIG. 3

FIG. 9 is a left elevational view of the end effector of FIG. 3 with aclevis removed;

FIG. 10 is a left elevational view of a coupling between the endeffector and the shaft assembly of the surgical instrument of FIG. 3;

FIG. 11 is a left elevational view of the coupling of FIG. 10 withadditional components removed;

FIG. 12 is a perspective view of the shaft assembly of the surgicalinstrument of FIG. 3;

FIG. 13 is a perspective view of a surgical instrument in accordancewith an embodiment of the present invention;

FIG. 14 is a cross-sectional view of a hand piece of the surgicalinstrument of FIG. 13;

FIG. 15 is a perspective view of an end effector of a surgicalinstrument having a cutting element in accordance with an embodiment ofthe present invention;

FIG. 16 is a perspective view of an end effector of a surgicalinstrument having a cutting element in accordance with an alternativeembodiment of the present invention;

FIG. 17 is a perspective view of an end effector of a surgicalinstrument having a cutting element extending from an electrode inaccordance with an alternative embodiment of the present invention;

FIG. 18 is a perspective view of an end effector of a surgicalinstrument having a cutting element configured to be energized inaccordance with an alternative embodiment of the present invention;

FIG. 19 is a detail view of an insulator positioned intermediate anelectrode and the cutting element of FIG. 18;

FIG. 20 is a perspective view of an end effector of a surgicalinstrument having a tapered profile in accordance with an alternativeembodiment of the present invention;

FIG. 21 is an elevational view of the end effector of FIG. 20;

FIG. 22 is a top view of the end effector of FIG. 20;

FIG. 23 is a perspective view of the end effector of FIG. 20 in an openconfiguration; and

FIG. 24 is an elevational view of the end effector of FIG. 20 in theconfiguration of FIG. 23.

Corresponding reference characters indicate corresponding partsthroughout the several views. The exemplifications set out hereinillustrate preferred embodiments of the invention, in one form, and suchexemplifications are not to be construed as limiting the scope of theinvention in any manner.

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those of ordinary skill in the art will understand that thedevices and methods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments and thatthe scope of the various embodiments of the present invention is definedsolely by the claims. The features illustrated or described inconnection with one exemplary embodiment may be combined with thefeatures of other embodiments. Such modifications and variations areintended to be included within the scope of the present invention.

The various embodiments described herein are related to electricaltherapy ablation devices. Generally, electrical therapy ablation devicescan comprise electrodes that can be positioned in, or in proximity to, atissue treatment region, or target site, within a patient. Thesedevices, and the surgical techniques for using the same, may be employedto treat tissue masses, tissue tumors, and lesions, for example, (all ofwhich are hereinafter referred to as ‘diseased tissue’) at the tissuetreatment region. In various embodiments, these devices can be utilizedin open surgical procedures as well as external and non-invasive medicalprocedures. In other various embodiments, these devices may be adaptedto provide minimally invasive access to the tissue treatment region oranatomic location, such as lung and liver tissue, for example, in orderto diagnose and treat the condition at the tissue treatment region moreaccurately and effectively. In various embodiments, portions of theelectrical therapy ablation devices may be introduced in the tissuetreatment region endoscopically (e.g., laparoscopically and/orthoracoscopically), or through a trocar extending through a smallincision. Portions of other devices may be introduced into the tissuetreatment region by way of a natural orifice through a cannula orcatheter. Minimally invasive procedures which introduce medicalinstruments to a tissue treatment region through a natural opening ofthe patient are known as Natural Orifice Translumenal Endoscopic Surgery(NOTES)™. In other embodiments, portions of the electrical therapydevices can be introduced percutaneously or in any combination of themethods described above.

Once positioned, the electrical therapy electrodes can deliverelectrical current to the treatment region. The electrical current canbe generated by a control unit or generator located external to thepatient, for example, where the electrical current may be characterizedby a particular waveform in terms of frequency, amplitude, and pulsewidth. Depending on the diagnostic or therapeutic treatment rendered,the diseased tissue can be electrically ablated or destroyed. Moreparticularly, the electrical therapy ablation devices may be employed todeliver sufficient energy to the diseased tissue to ablate or destroytumors, masses, lesions, and other abnormal tissue growths. In at leastone embodiment, the electrical therapy ablation devices and techniquesdescribed herein may be employed in the treatment of cancer by quicklycreating necrosis and destroying live cancerous tissue in-vivo. Suchdevices and techniques are further described in a commonly-owned,co-pending U.S. patent application Ser. No. 11/897,676, entitledELECTRICAL ABLATION SURGICAL INSTRUMENTS, Attorney Docket No.END6182USNP/070301, filed on Aug. 31, 2007, the entire disclosure ofwhich is hereby incorporated by reference herein.

In various embodiments, electrical therapy ablation may employelectroporation, or electropermeabilization, techniques where anexternally applied electric field (electric potential) significantlyincreases the electrical conductivity and permeability of a cell plasmamembrane. Electroporation is the generation of a destabilizing electricpotential across such biological membranes. In electroporation, poresare formed when the voltage across the cell plasma membrane exceeds itsdielectric strength. Electroporation destabilizing electric potentialsare generally in the range of several hundred volts across a distance ofseveral millimeters. Below certain magnitude thresholds, the electricpotentials may be applied across a biological membrane as a way ofintroducing some substance into a cell, such as loading it with amolecular probe, a drug that can change the function of the cell, apiece of coding DNA, or increasing the uptake of drugs in cells. If thestrength of the applied electrical field and/or duration of exposure toit are suitably chosen, the pores formed by the electrical pulse resealafter a short period of time, during such period extra-cellularcompounds may enter into the cell. Below a certain field threshold, theprocess is reversible and the potential does not permanently damage thecell membrane. This process may be referred to as reversibleelectroporation (RE). On the other hand, excessive exposure of livecells to large electric fields can cause apoptosis and/or necrosis—theprocesses that result in cell death. Excessive exposure of live cells tolarge excessive electrical fields or potentials across the cellmembranes causes the cells to die and therefore may be referred to asirreversible electroporation (IRE). Electroporation may be performedwith devices called electroporators. These appliances can create theelectric current and send it through the cell. Electroporators maycomprise two or more metallic (e.g., aluminum) electrically conductiveelectrodes connected to an energy source. The energy source can generatean electric field having a suitable characteristic waveform output interms of frequency, amplitude, and pulse width.

In various embodiments, an electrical ablation system may be employed inconjunction with a flexible endoscope, such as a GIF-100 model availablefrom Olympus Corporation, for example. In at least one such embodiment,the endoscope, a laparoscope, or a thoracoscope, for example, may beintroduced into the patient trans-anally through the colon, the abdomenvia an incision or keyhole and a trocar, or trans-orally through theesophagus, for example. These devices can assist the surgeon to guideand position the electrical ablation system near the tissue treatmentregion to treat diseased tissue on organs such as the liver, forexample. In another embodiment, these devices may be positioned to treatdiseased tissue near the gastrointestinal (GI) tract, esophagus, and/orlung, for example. In various embodiments, the endoscope may comprise aflexible shaft where the distal end of flexible shaft may comprise alight source, a viewing port, and at least one working channel. In atleast one such embodiment, the viewing port can transmit an image withinits field of view to an optical device such as a charge coupled device(CCD) camera within the endoscope, for example, so that an operator mayview the image on a display monitor (not shown).

In various embodiments, referring to FIG. 1, surgical instrument, orbipolar forceps, 20 can include an end effector, shaft assembly 22, andhand piece 24. In at least one embodiment, shaft assembly 22 cancomprise a flexible shaft of an endoscopic surgical instrument whereinat least portions of the end effector and shaft assembly 22 can beconfigured to be positioned within and/or inserted through a workingchannel of an endoscope. Hand piece 24 can be configured to be graspedby a surgeon and, in at least one embodiment, hand piece 24 can comprisea pistol grip including stationary member 26 and movable member, ortrigger, 28. In use, as described in greater detail below, trigger 28can be moved toward stationary member 26 as indicated by arrow 27, forexample, in order to operate the end effector within a surgical site.Although not illustrated, surgical instrument 20 can include a switchwhich can place the end effector in electrical communication with anelectrical source, or generator, via wires 30 and 32. In at least oneembodiment, wires 30 and 32 can terminate in connector 34 where,referring to FIG. 2, connector 34 can be configured to be operablyconnected to connector 36 of generator 38.

In various embodiments, referring to FIGS. 3-9, an end effector, such asend effector 50, for example, can include a grasping device comprisingfirst jaw member 52 and second jaw member 54, where at least one of jawmembers 52 and 54 can be moved relative to the other. In at least oneembodiment, jaw members 52 and 54 can be movably coupled to housing, orclevis, 56 such that they can be moved, or pivoted, between open andclosed positions about pivot pin 58. In use, jaw members 52 and 54 canbe positioned in their closed, or at least partially closed, positionsbefore they are inserted into a surgical site through a trocar, forexample. In various embodiments, jaw members 52 and 54 can be configuredsuch that they can be positioned within and/or inserted through aworking channel of an endoscope. Once positioned within the surgicalsite, jaw members 52 and 54 can then be reopened. In their openposition, jaw members 52 and 54 can be positioned on, or relative to,the targeted soft tissue within the surgical site. Thereafter, in atleast one embodiment, jaw members 52 and 54 can be pivoted into theirclosed position to hold the soft tissue therebetween. In variousembodiments, at least one of jaw members 52 and 54 can includeserrations, or teeth, 60 which can be configured to securely hold thesoft tissue therebetween.

In order to more easily position end effector 50, the shaft assemblyextending between end effector 50 and hand piece 24 can be flexible. Inat least one embodiment, referring to FIG. 3, shaft assembly 80 caninclude a flexible elongate member 82 and a flexible coil spring 84positioned therearound. In various embodiments, referring to FIGS. 7-11,a surgical instrument can further include adapter assembly 86 foroperably connecting end effector 50 to shaft assembly 80. In at leastone embodiment, adapter assembly 86 can include ring capture 88 whichcan include an aperture therein, or any other suitable feature, forreceiving and retaining an end of coil spring 84. Adapter assembly 86can further include bushing coupler 83 which can include projection 85,or any other suitable feature, which can be fixedly connected to housing56. In addition to the above, adapter assembly 86 can also include innerhousing coupler 87 which can be configured to connect ring capture 88 tobushing coupler 83 such that end effector 50 is correspondingly coupledto shaft assembly 80.

In order to move jaw members 52 and 54 between their open and closedpositions as described above, trigger 28 of hand piece 24 can be pivotedrelative to stationary member 26 such that trigger 28 can displaceactuator, or rod, 44 (FIG. 1) relative to shaft 22. In variousembodiments, actuator 44 can be round, or any other suitable shape, andcan be either solid or tubular. In either event, referring to FIG. 6,actuator rod 44 can be operably engaged with actuator 46 such that, whentrigger 28 is pivoted toward stationary member 26 as described above,actuator rod 44 and actuator 46 can be slid proximally such thatactuator 46 pulls on jaw links 53 and 55. It will be appreciated thatthe terms “proximal” and “distal” are used herein with reference to aclinician gripping hand piece 24 of instrument 20, for example. Thus,end effector 50 is distal with respect to hand piece 24. When jaw links53 and 55 are pulled proximally, jaw links 53 and 55 can apply a forceto jaws 52 and 54, respectively, such that they are pivoted about pivotpin 58 into their closed positions. In order to move jaws 52 and 54 intotheir open positions, trigger 28 can be moved away from stationaryportion 26 and, correspondingly, actuator rod 44 and actuator 46 can bemoved distally by trigger 28. Similarly, actuator 46 can move links 53and 55 distally such that such that links 53 and 55 apply a force tojaws 52 and 54 and rotate them about pivot pin 58 in the opposite, oropen, direction. Now referring to another exemplary embodimentillustrated in FIGS. 13 and 14, when trigger 28′ is pivotally moved(e.g., squeezed) in the direction indicated by arrow 29, actuator rod 44can be moved in the direction indicated by arrow 47, and the first andsecond jaw members 52 and 54 can close in the direction indicated byarrow 49. When trigger 28′ is pivotally moved (e.g., released) in thedirection indicated by arrow 31, actuator 44 can be moved in thedirection indicated by arrow 45, and the first and second jaw memberscan open in the direction indicated by arrow 51.

Further to the above, in various embodiments, at least a portion of thedistal end of actuator rod 44 can be fixedly received in shaft collar66′ (FIG. 14) such that, when collar 66′ is moved by trigger 28′,actuator 44 can be moved proximally and distally as described above. Inat least one embodiment, trigger 28′ can be operably engaged with pin67′ in shaft collar 66′ such that the rotational movement of trigger 28′can be converted to translational movement of shaft collar 66′. Moreparticularly, although not illustrated, trigger 28′ can include a camslot which is configured to receive pin 67′ such that, when trigger 28′is rotated as described above, the sidewalls of the slot can motivateshaft collar 66′, and actuator 44 operably engaged therewith, along apath defined by housing portion 65′. In various embodiments, althoughnot illustrated, hand piece 24′ can further include a biasing member, orspring, which is configured to bias trigger 28′, and jaw members 52 and54, into one of a closed or open position.

In at least one embodiment, referring to FIG. 14, hand piece 24′ canfurther include spring holders 68′ and 70′ where the spring can bepositioned therebetween. In various embodiments, shaft collar 66′ can beconnected to one of spring holders 68′ and 70′ and the other of springholders 68′ and 70′ can be connected to housing portion 65′. In suchembodiments, when shaft collar 66′ is moved relative to housing portion65′, one of spring holders 68′ and 70′ can be moved relative to theother such that the spring is placed in either tension or compressionand can apply a spring force to trigger 28′. In at least one embodiment,when trigger 28′ is released from its closed position as indicated byarrow 31, the spring force can bias trigger 28′ into its open positionas indicated by arrow 29. In various other embodiments, although notillustrated, trigger 28′ can be biased into its closed position or anyother suitable position. In at least one embodiment, trigger 28′ canfurther include latch 25′ which can be configured to hold trigger 28′ tostationary portion 26′ against the biasing force of the spring.

In various embodiments, referring to FIG. 2, hand piece 24 can includerotation knob 21 and, similarly, referring to FIG. 13, hand piece 24′can include rotation knob 21′, where rotation knobs 21 and 21′ can beconfigured to rotate an end effector of their respective surgicalinstruments relative to hand pieces 24 and 24′. In various embodiments,referring to FIGS. 13 and 14, a portion of actuator rod 44 can beslidably received within aperture 23′ in rotation knob 21′ wherein atleast one of the actuator rod 44 and aperture 23′ can include anon-circular profile. In such embodiments, the non-circular profile canallow actuator rod 44 to be rotated by knob 21′ yet allow actuator rod44 to slide relative thereto when it is moved proximally and distally bytrigger 28′ as described above. In at least one embodiment, whenrotation knob 21′ is rotated in the direction indicated by arrow 62, endeffector 50 can also rotated in the direction indicated by arrow 62.Similarly, when rotation knob 21′ is rotated in the direction indicatedby arrow 64, end effector 50 can be rotated in the direction indicatedby arrow 64. As a result of the above, jaw members 52 and 54 can berotated within the surgical site and can be more accurately positionedby a surgeon.

Once end effector 50 has been positioned in a surgical site and jawmembers 52 and 54 have been closed onto the soft tissue, as outlinedabove, the soft tissue can be treated by an electrical current thatpasses between jaw members 52 and 54. More particularly, in at least oneembodiment, surgical instrument 20 can include an electrical circuitwhich is configured to receive an electrical current from currentgenerator 38 (FIG. 2) and transmit the current to a first electrode 72positioned within jaw member 52 via first conductor, or wire, 30. Invarious embodiments, the current can be conducted through the softtissue positioned between jaw members 52 and 54 such that the currentflows into a second electrode 74 positioned in second jaw member 54. Thecurrent can return to electrical generator 38 through second conductor,or wire, 32 to complete the circuit. In at least one such embodiment,generator 38 can include plug 42 which can be configured to providecommercially available current to generator 38 where generator 38 can beconfigured to transform the current as needed. In at least oneembodiment, generator 38 can further include a switch, such as footpedal 40, for example, which can be configured to place surgicalinstrument 20 in electrical communication with generator 38. In variousembodiments, switch 40 can be utilized in addition to, or in lieu of, aswitch on surgical instrument 20.

In various embodiments, a surgical instrument in accordance with thepresent invention can be configured such that at least one electrode canbe selectively placed in electrical communication with a conductorassociated therewith. In at least one embodiment, referring to FIGS. 5and 6, first electrode 72 can be placed in electrical communication withfirst conductor 30 when jaw member 52 is in a first position and can beplaced out of electrical communication with conductor 30 when jaw member52 is in a second position, for example. In at least one suchembodiment, first electrode 72 can be configured to abut, or contact,contact end 33 of conductor 30 when jaw 52 is in its closed, or at leasta substantially closed, position such that current can flow betweenfirst electrode 72 and first conductor 30. In such embodiments, firstelectrode 72 can be moved away from contact end 33 when jaw member 52 ismoved into its open, or at least a substantially open, position suchthat current cannot flow between first electrode 72 and first conductor30. In various embodiments, conductor 30 does not have to be attached tofirst electrode 72 and, as a result, first electrode 72 can be movedrelative to conductor 30.

Further to the above, in at least one embodiment, conductor 30,including contact end 33, can remain stationary, or at leastsubstantially stationary, when first electrode 72 is moved between firstand second positions as described above and, as a result, conductor 30does not have to be bent or stretched to accommodate the movement offirst electrode 72. In various circumstances, as a result, thelikelihood that conductor 30 may break or become otherwise damaged canbe reduced. As illustrated in FIGS. 5 and 6, surgical instrument 20 caninclude one or more additional electrodes which can be selectivelyplaced in electrical communication with a conductor associatedtherewith. In at least one embodiment, similar to the above, secondelectrode 74 can be placed in electrical communication with secondconductor 32 when jaw member 54 is in a first position and can be placedout of electrical communication with second conductor 32 when jaw member54 is in a second position, for example. Although not illustrated,surgical instrument 20 can include one or more stationary jaws andelectrodes which do not move relative to a corresponding conductor. Insuch embodiments, the conductor may be attached to the stationaryelectrode, for example.

In various embodiments, first electrode 72 and first conductor 30 may becoupled to the positive terminal of generator 38 and second electrode 74and second conductor 32 may be coupled to the negative terminal. Inother various embodiments, this arrangement may be reversed. In eitherevent, the switches described above, including foot pedal 40 (FIG. 2),may be placed intermediate, or in series between, the positive terminaland the electrode coupled thereto. In such embodiments, the switch mayprevent current from flowing from the generator to this electrode untilthe switch is actuated. Absent such a switch, current could flow throughthe circuit comprising first conductor 30, second conductor 32, firstelectrode 72, and second electrode 74 when the electrodes are placed inelectrical communication with the conductors. In these embodiments,current could be immediately transferred to the electrodes, and the softtissue positioned therebetween, when jaw members 52 and 54 are movedinto their closed, or at least substantially closed, positions. Whilesuch embodiments can be useful, various surgical techniques may requirethat the electrodes be manipulated or repositioned on the soft tissueafter the jaw members have been closed thereon. In such embodiments, thejaw members could be closed onto the soft tissue and the current couldbe delivered to the electrodes when a switch is activated as describedabove.

In various embodiments, referring to FIGS. 4 and 5, each jaw member 52and 54 can further include an insulator 75 which can be configured toprevent current from flowing from electrodes 72 and 74, respectively, tothe other portions of the jaw members. More particularly, absent aninsulator 75 positioned intermediate second electrode 74 and outerportion 76 of jaw 54, for example, the current may flow betweenelectrode 74 to outer portion 76 and then flow into adjacent tissuewhich is not the targeted tissue. In at least one embodiment, insulator75 may be at least partially comprised of a ceramic material, forexample. In various embodiments, conductors 30 and 32 can be comprisedof insulated wires. For example, each conductor can include an innercore comprised, of copper, brass, and/or aluminum, for example, and anouter jacket, or sheath, which can cover the core, wherein the jacketcan be comprised of PVC or any other suitable polymer, for example. Invarious embodiments, electrodes 72 and 74 can be comprised of anysuitable conductive material such as gold plated stainless steel, forexample. In various embodiments, referring to FIG. 12, elongate member82 can include at least one aperture, or lumen, 81 extendingtherethrough which can be configured to receive and protect conductors,or wires, 30 and 32 extending between end effector 50 and hand piece 24as described above. In various embodiments, a lumen 81 can be configuredto receive actuator 44 which, as described above, is operably engagedwith hand piece 24 and end effector 50.

In various embodiments, an electrode can be formed having asubstantially flat paddle-like shape, and/or any other suitable shape.In such embodiments, as described above, the electrode can include aflat surface which can be configured to abut contact end 33 of aconductor. In at least one embodiment, the inner core of the conductorcan be configured to touch a portion of this flat surface and place theelectrode and the conductor in electrical communication. In variousother embodiments, although not illustrated, the electrode can includean aperture, or receptacle, which can be configured to receive contactend 33 therein, for example. In at least one embodiment, contact end 33can be configured to abut a sidewall of the receptacle or it can beconfigured to fit snugly therein. In either event, the engagementbetween the receptacle and contact 33 can prevent, or at least reducethe possibility of, relative movement between the conductor and theelectrode when the jaw member is in its closed position. Such relativemovement could cause intermittencies in the current flowing therebetweenwhich could affect the reliability of the surgical instrument. Invarious embodiments, contact end 33 can comprise an electrical contactwhich is soldered onto, or otherwise attached to, the end of the innercore of the conductor. Such electrical contacts can be configured suchthat they fit snugly within the receptacles in the electrodes and mayrequire a force to remove them therefrom.

In various embodiments, a bipolar forceps having two or more electrodescan be utilized to seal a vessel, such as a blood vessel, for example.In at least one embodiment, the electrodes can be positioned against, oradjacent to, the vessel and energy can be supplied to the electrodes. Invarious circumstances, the energy can be sufficient to at leastsubstantially seal the vessel such that blood does not substantiallyflow therethrough. In at least one surgical technique, the bipolarforceps can be used to thermally seal the vessel in two locations suchthat the vessel can be incised, or transected, at a location positionedintermediate the two sealed locations. In various embodiments, thebipolar forceps can include a cutting element which can be configured toincise the vessel. Such bipolar forceps can reduce the complexity ofvarious surgical techniques by allowing a surgeon to seal and transectsoft tissue with a single surgical instrument as opposed to using atleast two surgical instruments which were previously required.

Referring to FIG. 15, surgical instrument 120 can include first jawmember 152 and second jaw member 154 wherein, similar to the above,first jaw member 152 can include first electrode 172 and, in addition,second jaw member 154 can include second electrode 174. In at least oneembodiment, surgical instrument 120 can further include cutting element190, wherein cutting element 190 can be configured to incise softtissue, for example, positioned intermediate jaw members 152 and 154. Invarious embodiments, cutting element 190 can be configured to be movedrelative to jaw members 152 and 154 and/or electrodes 172 and 174. Moreparticularly, in at least one embodiment, cutting element 190 can bemoved between a first, or proximal, position, as illustrated in FIG. 15,to a second, or distal, position, within distal end 192. In variousalternative embodiments, the cutting element can be moved from a distalposition to a proximal position to incise the soft tissue, for example.In either event, in at least one embodiment, cutting element 190 caninclude a sharp, or knife, edge configured to incise the soft tissue,for example. In various embodiments, second electrode 174 can includeslot 191 which can be configured to slidably receive cutting element 190and guide it along a predetermined path. In at least one embodiment, asillustrated in FIG. 15, the predetermined path can be linear or at leastsubstantially linear. In other various embodiments, the predeterminedpath can be curved and/or curvilinear. In any event, in at least oneembodiment, first electrode 172 can include a slot therein which canalso be configured to slidably receive and guide cutting element 190.

In various embodiments, referring to FIG. 16, surgical instrument 220can include first jaw member 252 and second jaw member 254 where,similar to the above, jaw members 252 and 254 can be positioned relativeto a vessel, for example, such that electrodes within the jaw memberscan be utilized to cauterize or seal the vessel. In at least oneembodiment, surgical instrument 220 can further include cutting element,or cutting barrel, 290 movably attached thereto wherein cutting barrel290 can be moved between first and second positions similar to theabove. In use, jaw members 252 and 254 can be used to at least partiallyclamp the vessel therebetween such that cutting barrel 290 can be slidover the at least partially closed jaws. In other various embodiments,cutting barrel 290 can be slid against jaw members 252 and 254 in orderto push them into an at least partially closed position. In eitherevent, in at least one embodiment, cutting barrel 290 can includeaperture 293 extending therethrough which can be configured to receiveat least a portion of jaws 252 and 254 as cutting barrel 290 is movedtoward distal end 292. In at least one surgical technique, a vessel canbe thermally sealed at two locations by electrodes 72 and 74 asdescribed above. Thereafter, jaws 252 and 254 can be positionedintermediate the two sealed locations, jaws 252 and 254 can be at leastpartially closed onto the vessel, and cutting barrel 290 can be sliddistally until cutting edge 294 contacts and incises the vessel.

In various embodiments, referring to FIG. 17, surgical instrument 320can include first jaw member 352 and second jaw member 354 wherein,similar to the above, first jaw member 352 can include first electrode372 and, in addition, second jaw member 354 can include second electrode374. In at least one embodiment, at least one of first electrode 372 andsecond electrode 374 can include at least one cutting element 390extending therefrom. In various embodiments, cutting element 390 cancomprise a projection, or ‘high point’, having at least one cutting edge394 configured to incise, or otherwise treat, soft tissue, such as avessel, for example, when jaw members 352 and 354 are closed onto thesoft tissue. In at least one embodiment, cutting edge 394 can be sharpenough to incise the soft tissue when a closing force is applied to jawmembers 352 and 354. In various embodiments, energy can be applied tothe cutting element via the electrode in order for the cutting elementto transect the tissue. In such embodiments, the density of the energywithin the electrode can be concentrated at the projection, or highpoint, of the electrode owing to the reduced surface area of theelectrode in contact with the soft tissue. In various embodiments,referring to FIG. 18, surgical instrument 420 can include first jawmember 452 and second jaw member 454 wherein, similar to the above,first jaw member 452 can include first electrode 472 and, in addition,second jaw member 454 can include second electrode 474. In at least oneembodiment, surgical instrument 420 can further include cutting element490, wherein cutting element 490 can be configured to incise softtissue, for example, positioned intermediate jaw members 452 and 454. Invarious embodiments, similar to the above, cutting element 490 can beconfigured to be moved relative to jaw members 452 and 454 and/orelectrodes 472 and 474 along a predetermined path. In at least oneembodiment, at least one of electrodes 472 and 474 and/or jaw members452 and 454 can include a slot 491 therein which can be configured toslidably receive cutting element 490.

In various embodiments, cutting element 490 can be energized to incise,or otherwise treat, the soft tissue positioned intermediate jaw members452 and 454. In at least one embodiment, cutting element 490 can beplaced in electrical communication with a monopolar output of anelectrosurgical generator such that current can flow from the generatorinto the soft tissue via cutting element 490. In order to complete themonopolar circuit, a return electrode, or pad, can be placed in contactwith the patient's body and can be placed in electrical communicationwith the generator and/or another suitable ground. In other variousembodiments, although not illustrated, surgical instrument 420 caninclude a return circuit for the electrical current. In either event,referring to FIG. 19, jaw member 454 can further include insulator 495positioned intermediate cutting element 490 and second electrode 474 toelectrically insulate cutting element 490 from electrode 474. In atleast one embodiment, insulator 495 can define slot 491 such thatcutting element 490 is at least substantially surrounded by insulator495. Insulator 495 can be comprised of any suitable material such as aceramic material, for example.

In at least one surgical technique, bipolar electrodes 472 and 474 canbe utilized to at least partially seal a vessel as described above.Thereafter, electrodes 472 and 474 can be positioned intermediate thetwo seals and cutting element 490 can be slid until it touches thevessel. To incise the vessel, the surgeon can operate a switch, forexample, to allow current to flow to cutting member 490. In variouscircumstances, depending on the frequency and voltage of the current,for example, cutting element 490 configured to cut and/or coagulate thesoft tissue. In either event, surgical instrument 420 can include aswitch, for example, which can be configured to place surgicalinstrument 420 in a plurality of operating modes. In at least oneembodiment, the switch can place instrument 420 in a first operatingmode in which electrical energy is supplied to electrodes 472 and 474,but not to cutting element 490. The switch can also place instrument 420in a second operating mode in which electrical energy is supplied tocutting element 490, but not electrodes 472 and 474. In suchembodiments, the possibility of energy being unintentionally transmittedto the targeted soft tissue, or the surrounding soft tissue, can bereduced. In at least one embodiment, cutting element 490 can furtherinclude cutting edge 494 which can be configured to incise, or bluntlydissect, the soft tissue. Such embodiments can provide a surgeon withseveral options for incising soft tissue.

In various embodiments, referring to FIGS. 20-24, a bipolar forceps caninclude first and second jaw members wherein at least one of the jawmembers can include a substantially tapered profile. More particularly,in at least one embodiment, surgical instrument 520 can include endeffector 550 having proximal end 596 and distal end 592 where endeffector 550 can be tapered between proximal end 596 and distal end 592.In various embodiments, proximal end 596 can define a first perimeterand distal end 592 can define a second perimeter wherein the firstperimeter can be larger than the second perimeter. Similarly, proximalend 596 can include a cross-section defined by a first diameter anddistal end 592 can include a cross-section defined by a second diameterwherein the first diameter can be larger than the second diameter.Although embodiments where ends 592 and 596 have circular cross-sectionsare envisioned, other embodiments having non-circular cross-sections arealso possible. In either event, in various embodiments, a ‘tapered’ endeffector can include a cross-section which becomes gradually smallerbetween proximal end 596 and distal end 592. Such a taper can beconstant along the length of end effector 550 or the taper can includeat least two sections having different tapered profiles. In eitherevent, as described in greater detail below, a bipolar forceps having atapered end effector can be useful in various surgical techniques.

In at least one surgical technique, distal end 592 can be positionedintermediate a vessel and soft tissue surrounding the vessel in order toseparate the vessel from the soft tissue. More particularly, endeffector 550 can be positioned intermediate the vessel and the softtissue in a substantially closed position and can be opened such thatjaw members 552 and 554 contact the vessel and soft tissue and push themaway from each other. In various circumstances, end effector 550 can beopened and closed several times to enlarge a hole between the vessel andsoft tissue such that the vessel and the soft tissue can be furtherseparated. In various embodiments, again referring to FIGS. 20-24, atleast one of jaw members 552 and 554 can further include ridges, teeth,and/or a textured outer surface configured to grip the soft tissueand/or vessel. In at least one embodiment, jaw member 552, for example,can include ridges 597 extending therefrom along a line defined betweendistal end 592 and proximal end 596. In various embodiments, ridges 597can be configured such that, when the jaw members contact the softtissue and/or vessel as described above, the jaw members can pull thesoft tissue and vessel therewith. In effect, ridges 597, for example,can prevent, or at least inhibit, jaw members 552 and 554 from slidingpast the soft tissue and/or vessel when the jaw members are opened.

In various embodiments, referring to FIGS. 21 and 24, jaw member 552,for example, can include tapered portion 598 and bullet nose portion599. In at least one embodiment, both tapered portion 598 and bulletnose portion 599 can include ridges 597, for example, extendingtherefrom. In such embodiments, bullet nose portion 599 can beespecially configured to be burrowed between the vessel and thesurrounding soft tissue, as described above, as ridges 597 extendingfrom bullet nose portion 599 can facilitate the creation of a hole inthe connective tissue intermediate the vessel and the soft tissue. Inaddition to or in lieu of the above, the outer surfaces of jaw members552 and 554 can include an outer surface having a rough texture whichcan also be configured to prevent, or at least reduce, slipping betweenthe jaw members and the soft tissue and/or vessel. In at least oneembodiment, the outer surface of jaw members 552 and 554 can be abraded.In various embodiments, a rough coating can be sprayed onto the jawmembers. In either event, once the vessel has been at least partiallyseparated from the soft tissue, one of jaw members 552 and 554 can bepositioned intermediate the vessel and the soft tissue and the other ofjaw members 552 and 554 can be positioned on the opposite side of thevessel. Thereafter, the electrodes positioned within jaw members 552 and554 can be utilized to thermally seal the vessel as described above.

In at least one embodiment, the first and second electrodes can beadapted to receive an irreversible electroporation (IRE) waveform froman IRE generator. In another embodiment, the first and second electrodescan be adapted to receive a radio frequency (RF) waveform from an RFgenerator. In various embodiments, the electrical waveform generator maybe a conventional, bipolar/monopolar electrosurgical IRE generator suchas one of many models commercially available, including Model Number ECM830, available from BTX Molecular Delivery Systems Boston, Mass. The IREgenerator can generate electrical waveforms having predeterminedfrequency, amplitude, and pulse width. In various circumstances, theapplication of these electrical waveforms to the cell membranes of thediseased tissue causes the diseased cells to die. Thus, the IREelectrical waveforms may be applied to the cell membranes of diseasedtissue in the tissue treatment region in order to kill the diseasedcells and ablate the diseased tissue. IRE electrical waveforms suitableto destroy the cells of diseased tissues are generally in the form ofdirect current (DC) electrical pulses delivered at a frequency in therange of 1-20 Hz, amplitude in the range of 100-1000 VDC, and pulsewidth in the range of 0.01-100 ms. For example, an electrical waveformhaving amplitude of 500 VDC and pulse duration of 20 ms may be deliveredat a pulse repetition rate or frequency of 10 HZ to destroy a reasonablylarge volume of diseased tissue. Unlike RF ablation systems whichrequire high powers and energy input into the tissue to heat anddestroy, IRE requires very little energy input into the tissue, ratherthe destruction of the tissue is caused by high electric fields. It hasbeen determined that in order to destroy living tissue, the electricalwaveforms have to generate an electric field of at least 30,000 V/m inthe tissue treatment region. The embodiments, however, are not limitedin this context.

In at least one embodiment, the electrical waveform generator maycomprise a radio frequency (RF) waveform generator. The RF generator maybe a conventional, bipolar/monopolar electrosurgical generator such asone of many models commercially available, including Model Number ICC350, available from Erbe, GmbH. Either a bipolar mode or monopolar modemay be used. When using the bipolar mode with two electrodes, oneelectrode can be electrically connected to one bipolar polarity, and theother electrode can be electrically connected to the opposite bipolarpolarity. If more than two electrodes are used, the polarity of theelectrodes may be alternated so that any two adjacent electrodes haveopposite polarities.

The devices disclosed herein can be designed to be disposed of after asingle use, or they can be designed to be used multiple times. In eithercase, however, the device can be reconditioned for reuse after at leastone use. Reconditioning can include any combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, the devicecan be disassembled, and any number of the particular pieces or parts ofthe device can be selectively replaced or removed in any combination.Upon cleaning and/or replacement of particular parts, the device can bereassembled for subsequent use either at a reconditioning facility, orby a surgical team immediately prior to a surgical procedure. Thoseskilled in the art will appreciate that reconditioning of a device canutilize a variety of techniques for disassembly, cleaning/replacement,and reassembly. Use of such techniques, and the resulting reconditioneddevice, are all within the scope of the present application.

Preferably, various embodiments of the invention described herein willbe processed before surgery. First, a new or used instrument is obtainedand if necessary cleaned. The instrument can then be sterilized. In onesterilization technique, the instrument is placed in a closed and sealedcontainer, such as a plastic or TYVEK bag. The container and instrumentare then placed in a field of radiation that can penetrate thecontainer, such as gamma radiation, x-rays, or high-energy electrons.The radiation kills bacteria on the instrument and in the container. Thesterilized instrument can then be stored in the sterile container. Thesealed container keeps the instrument sterile until it is opened in themedical facility. It is preferred that the instrument is sterilized.This can be done by any number of ways known to those skilled in the artincluding beta or gamma radiation, ethylene oxide, steam.

While this invention has been described as having exemplary designs, thepresent invention may be further modified within the spirit and scope ofthe disclosure. This application is therefore intended to cover anyvariations, uses, or adaptations of the invention using its generalprinciples. Further, this application is intended to cover suchdepartures from the present disclosure as come within known or customarypractice in the art to which this invention pertains. Any patent,publication, or other disclosure material, in whole or in part, that issaid to be incorporated by reference herein is incorporated herein onlyto the extent that the incorporated materials does not conflict withexisting definitions, statements, or other disclosure material set forthin this disclosure. As such, and to the extent necessary, the disclosureas explicitly set forth herein supersedes any conflicting materialincorporated herein by reference. Any material, or portion thereof, thatis said to be incorporated by reference herein, but which conflicts withexisting definitions, statements, or other disclosure material set forthherein will only be incorporated to the extent that no conflict arisesbetween that incorporated material and the existing disclosure material.

1. A surgical instrument for treating soft tissue, comprising: aflexible shaft; a housing extending from said flexible shaft; a jawmovably connected to said housing, wherein said jaw is configured to beinserted through a working channel of an endoscope, wherein said jaw isselectively movable between a first position and a second position, andwherein said jaw includes: an electrode configured to be placed inelectrical communication with an energy source and transmit energy tothe soft tissue; and a cutting element configured to incise the softtissue.
 2. The surgical instrument of claim 1, wherein said cuttingelement is movable relative to said electrode.
 3. The surgicalinstrument of claim 2, wherein said electrode includes a slot configuredto at least partially receive said cutting element, and wherein saidcutting element is configured to slide within said slot.
 4. The surgicalinstrument of claim 2, wherein said cutting element is slidable betweena first position and a second position, and wherein said electrode is atleast partially positioned within said cutting element when said cuttingelement is in said second position.
 5. The surgical instrument of claim1, wherein said cutting element extends from said electrode.
 6. Thesurgical instrument of claim 1, wherein said cutting element isconfigured to be placed in electrical communication with an energysource.
 7. The surgical instrument of claim 6, further comprising aninsulator positioned intermediate said cutting element and saidelectrode, wherein said insulator is configured to electrically insulatesaid cutting element from said electrode.
 8. The surgical instrument ofclaim 6, wherein said cutting element is movable relative to saidelectrode.
 9. The surgical instrument of claim 1, wherein said cuttingelement is movable relative to said electrode, and wherein said cuttingelement is positioned around said jaw member.
 10. A method forprocessing an instrument for surgery, the method comprising: obtainingthe surgical instrument of claim 1; sterilizing the surgical instrument;and storing the surgical instrument in a sterile container.
 11. Asurgical instrument for treating soft tissue, comprising: a flexibleshaft; a first jaw; a second jaw movably coupled to said first jaw,wherein said first and second jaws are configured to be inserted througha working channel of an endoscope, wherein said second jaw isselectively movable between a first position and a second position; anelectrode configured to be placed in electrical communication with anenergy source and transmit energy to the soft tissue; and a cuttingelement configured to incise the soft tissue.
 12. The surgicalinstrument of claim 11, wherein said cutting element is movable relativeto said electrode.
 13. The surgical instrument of claim 12, wherein saidelectrode includes a slot configured to at least partially receive saidcutting element, and wherein said cutting element is configured to slidewithin said slot.
 14. The surgical instrument of claim 12, wherein saidcutting element is slidable between a first position and a secondposition, and wherein said electrode is at least partially positionedwithin said cutting element when said cutting element is in said secondposition.
 15. The surgical instrument of claim 11, wherein said cuttingelement extends from said electrode.
 16. The surgical instrument ofclaim 11, wherein said cutting element is configured to be placed inelectrical communication with an energy source.
 17. The surgicalinstrument of claim 16, further comprising an insulator positionedintermediate said cutting element and said electrode, wherein saidinsulator is configured to electrically insulate said cutting elementfrom said electrode.
 18. The surgical instrument of claim 16, whereinsaid cutting element is movable relative to said electrode.
 19. Thesurgical instrument of claim 11, wherein said cutting element is movablerelative to said electrode, and wherein said cutting element ispositioned around at least one of said first and second jaw members. 20.A method for processing an instrument for surgery, the methodcomprising: obtaining the surgical instrument of claim 11; sterilizingthe surgical instrument; and storing the surgical instrument in asterile container.
 21. A surgical instrument for treating soft tissue,comprising: a flexible shaft; a first jaw; a second jaw movably coupledto said first jaw, wherein said second jaw is movable between a firstposition and a second position, wherein said first and second jaws areconfigured to be inserted through a working channel of an endoscope,wherein said second jaw includes a proximal portion and a distalportion, and wherein said second jaw member is tapered between saidproximal portion and said distal portion; and an electrode configured tobe placed in electrical communication with an energy source and transmitenergy to the soft tissue.
 22. The surgical instrument of claim 21,wherein said second jaw includes an outer surface having a plurality ofridges configured to engage the soft tissue.
 23. The surgical instrumentof claim 21, wherein said second jaw includes an outer surface having atextured surface configured to engage the soft tissue.
 24. The surgicalinstrument of claim 21, wherein said second jaw includes an outersurface having at least one tooth extending therefrom configured toengage the soft tissue.
 25. A method for processing an instrument forsurgery, the method comprising: obtaining the surgical instrument ofclaim 21; sterilizing the surgical instrument; and storing the surgicalinstrument in a sterile container.